MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-12-03 for ZYNEX NEXWAVE manufactured by Zynex Medical, Inc..
[5764900]
Pt reported unit burned her (lower back area). She came to the main office, dropped the unit off in person and showed the redness on her lower back to the qual mgr. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723686-2014-00008 |
| MDR Report Key | 4621115 |
| Report Source | 04 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-11-06 |
| Date Mfgr Received | 2014-11-06 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2015-05-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 9990 PARK MEADOWS DR |
| Manufacturer City | LONE TREE CO 80124 |
| Manufacturer Country | US |
| Manufacturer Postal | 80124 |
| Manufacturer Phone | 8004956670 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | COMBO ELECTRICAL STIMULATOR, IPF, GZJ, LIH |
| Product Code | IPF |
| Date Received | 2014-12-03 |
| Returned To Mfg | 2014-11-06 |
| Model Number | NEXWAVE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYNEX MEDICAL, INC. |
| Manufacturer Address | LONE TREE CO 80124 US 80124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-03 |